Recording type 2 diabetes mellitus in a standardised central Saudi database: a retrospective validation study.

OBJECTIVES: This study was conducted to assess the validity of recording (and the original diagnostic practice) of type 2 diabetes mellitus at a hospital whose records were integrated to a centralised database (the standardised common data model (CDM) of the Saudi National Pharmacoepidemiologic Database (NPED)). DESIGN: A retrospective single-centre validation study. SETTINGS: Data of the study participants were extracted from the CDM of the NPED (only records of one tertiary care hospital were integrated at the time of the study) between 1 January 2013 and 1 July 2018. PARTICIPANTS: A random sample of patients with type 2 diabetes mellitus (≥18 years old and with a code of type 2 diabetes mellitus) matched with a control group (patients without diabetes) based on age and sex. OUTCOME MEASURES: The standardised coding of type 2 diabetes in the CDM was validated by comparing the presence of diabetes in the CDM versus the original electronic records at the hospital, the recording in paper-based medical records, and the physician re-assessment of diabetes in the included cases and controls, respectively. Sensitivity, specificity, positive predictive value and negative predictive value were estimated for each pairwise comparison using RStudio V.1.4.1103. RESULTS: A total of 437 random sample of patients with type 2 diabetes mellitus was identified and matched with 437 controls. Only 190 of 437 (43.0%) had paper-based medical records. All estimates were above 90% except for sensitivity and specificity of CDM versus paper-based records (54%; 95% CI 47% to 61% and 68%; 95% CI 62% to 73%, respectively). CONCLUSIONS: This study provided an assessment to the extent of which only type 2 diabetes mellitus code can be used to identify patients with this disease at a Saudi centralised database. A future multi-centre study would help adding more emphasis to the study findings.

Antimicrobial Sales Comparison before and after the Implementation of Nationwide Restriction Policy in Saudi Arabia.

Antimicrobial dispensing without a prescription has been identified as a significant contributor to the burgeoning crisis of antimicrobial resistance. To combat this, the Saudi Ministry of Health introduced a stringent antimicrobial restriction policy in mid-2018, mandating prescriptions for all antimicrobial drug dispensations at pharmacies. Therefore, this study aimed to assess the immediate impact of this policy on retail antimicrobial sales. To do so, we analyzed annual sales data from 2017 to 2019 sourced from the IQVIA-MIDAS® database, which included a range of antimicrobials, such as antibiotics, antifungals, and other related agents. The analysis revealed a notable reduction in overall antimicrobial sales by 23.2%, decreasing from 818.9 million SAR in 2017 to 648.4 million SAR in 2019. While the Wilcoxon signed-rank test indicated a statistically significant median reduction in total antimicrobial sales post-policy implementation (p = 0.0397), it is important to acknowledge that the long-term effects and adherence to the policy require further investigation. Notably, sales of amoxicillin dropped by 70% in 2019 compared to 2017, contributing largely to the decline. Conversely, a continuous increase in sales of some antimicrobial drugs following the restriction policy was observed, led by amoxicillin/clavulanic acid. Our data support the implementation of antimicrobial restriction measures as an effective means of controlling excessive antimicrobial sales and dispensing without prescriptions.

The impact of regulatory restrictions on pregabalin use in Saudi Arabia: An interrupted time series analysis.

PURPOSE: The Saudi Food and Drug Authority (SFDA) added pregabalin to the list of controlled substances in December 2017 to minimize the risk of its possible abuse and misuse. This study was aimed at assessing the impact of this decision on the overall use of pregabalin in Saudi Arabia and in comparison with drugs prescribed to treat neuropathic pain (i.e., vs. gabapentin, tramadol, duloxetine, and amitriptyline). METHODS: This was an interrupted time-series analysis of the Saudi quarterly sale data of the study drugs from October/2015 to September/2020. These data were obtained from IQVIA and were converted into use estimates (defined daily dose per 1000 inhabitant-days [DDD/TID]). Segmented regression models were conducted to assess the direct (level) and prolonged (trend) changes in use data after the decision. All analyses were completed using RStudio Version 1.4.1103. RESULTS: Before the SFDA's decision, there was an increased quarter-to-quarter use of pregabalin (DDD/TID: 0.16; 95% confidence interval [CI] 0.04 to 0.28). Pregabalin overall use dropped sharply by -1.85 DDD/TID (95% CI -2.71 to -0.99) directly after the decision with a prolonged quarter-to-quarter declining effect (DDD/TID: -0.22, CI to -0.37 to -0.05). The decision was associated with a direct increase in the use of gabapentin by 0.62 DDD/TID (95% CI 0.52-0.72) without any impact on the use of other drugs. CONCLUSIONS: The results of our study showed that the SFDA decision was associated with a decrease in the overall use of pregabalin, which may help minimize the risk of its abuse and misuse.